Vermillion, Inc.
Aspira Women's Health is dedicated to the discovery, development, and commercialization of AI-powered, non-invasive diagnostic tests for gynecologic diseases, including ovarian cancer and endometriosis. They develop tests such as OvaWatch®, Ova1Plus®, and upcoming tests like EndoCheck℠, aiming to improve early detection, risk assessment, and personalized care for women worldwide. Their mission is to radically improve health outcomes for individuals with a female reproductive system through innovative diagnostic solutions.
Industries
Nr. of Employees
medium (51-250)
Vermillion, Inc.
1250 Capital of Texas Hwy South, Building B, Suite 200, Austin, TX 78746
Patents
Products
OvaWatch (non-invasive risk assessment for indeterminate/benign adnexal masses)
Non-invasive blood-based risk assessment intended for patients with adnexal masses assessed as indeterminate or benign by initial clinical evaluation; provides a personalized malignancy risk score and supports longitudinal monitoring. The test has received New York State CLEP approval and is distributed through reference laboratory partnerships in certain regions.
Ova1Plus (reflex multivariate index assay for surgical management)
Reflex multivariate index assay workflow used when surgical management is planned; an initial multivariate protein biomarker assay is performed and an automated second-stage reflex algorithm is applied for intermediate results to refine specificity and support surgical referral decisions.
ENDOinform (in-development multi-analyte endometriosis test)
In-development blood-based diagnostic intended to identify endometriosis by combining circulating microRNA and protein biomarkers with patient metadata and machine-learning analytics; development funded in part by a milestone-based ARPA-H award to accelerate development and commercialization.
OvaWatch (non-invasive risk assessment for indeterminate/benign adnexal masses)
Non-invasive blood-based risk assessment intended for patients with adnexal masses assessed as indeterminate or benign by initial clinical evaluation; provides a personalized malignancy risk score and supports longitudinal monitoring. The test has received New York State CLEP approval and is distributed through reference laboratory partnerships in certain regions.
Ova1Plus (reflex multivariate index assay for surgical management)
Reflex multivariate index assay workflow used when surgical management is planned; an initial multivariate protein biomarker assay is performed and an automated second-stage reflex algorithm is applied for intermediate results to refine specificity and support surgical referral decisions.
ENDOinform (in-development multi-analyte endometriosis test)
In-development blood-based diagnostic intended to identify endometriosis by combining circulating microRNA and protein biomarkers with patient metadata and machine-learning analytics; development funded in part by a milestone-based ARPA-H award to accelerate development and commercialization.
Services
Enables partner clinical laboratories to run validated diagnostic assays locally using secured interfaces and licensed algorithms, with validation assistance, systems integration, and operational support.
Centralized processing of clinician-ordered blood-based diagnostic assays for adnexal masses with specimen logistics, analytic processing, and standardized reporting within targeted turnaround times.
Design and deployment of EMR-embedded clinical decision support modules to standardize care pathways and aggregate structured clinical data across provider networks.
Technical assistance for assay validation, instrument integration, secure interface deployment, and workflow optimization to enable local test performance and regulatory-aligned validation documentation.
Partnerships with large reference laboratories to co-market and distribute diagnostic tests to provider clients in targeted regions, leveraging partner lab networks for broader access.
Distribution of test kits to provider offices, specimen logistics guidance, insurance billing and patient financial assistance programs, and price-transparency resources.
Enables partner clinical laboratories to run validated diagnostic assays locally using secured interfaces and licensed algorithms, with validation assistance, systems integration, and operational support.
Centralized processing of clinician-ordered blood-based diagnostic assays for adnexal masses with specimen logistics, analytic processing, and standardized reporting within targeted turnaround times.
Design and deployment of EMR-embedded clinical decision support modules to standardize care pathways and aggregate structured clinical data across provider networks.
Technical assistance for assay validation, instrument integration, secure interface deployment, and workflow optimization to enable local test performance and regulatory-aligned validation documentation.
Partnerships with large reference laboratories to co-market and distribute diagnostic tests to provider clients in targeted regions, leveraging partner lab networks for broader access.
Distribution of test kits to provider offices, specimen logistics guidance, insurance billing and patient financial assistance programs, and price-transparency resources.
Expertise Areas
- AI/ML diagnostic algorithm development
- Biomarker discovery and multimodal assay development (microRNA + protein)
- Multivariate index assay design and reflex testing workflows
- Clinical validation and external validation studies
Key Technologies
- Circulating microRNA biomarker panels
- Protein biomarker immunoassays
- Neural networks and deep learning models
- Multivariate index assay methodology
News & Updates
The company received the first $2 million from the ARPA-H Sprint for Women’s Health Award, supporting the development of a blood test for endometriosis.
A study highlighting the accuracy of a multimodal assay combining miRNA with protein biomarkers, age, and menopausal status for early-stage ovarian cancer detection.
First FDA approval of Ova1 proteomic assay
Ova1 was the first proteomic in vitro diagnostic multivariate index assay approved by the FDA for clinical use in assessing ovarian cancer malignancy risk.
FDA approval of Overa risk assessment
Overa, Aspira's second-generation blood-based ovarian cancer risk assessment, received FDA approval with an improved positive predictive value of 79%.
The company received the first $2 million from the ARPA-H Sprint for Women’s Health Award, supporting the development of a blood test for endometriosis.
A study highlighting the accuracy of a multimodal assay combining miRNA with protein biomarkers, age, and menopausal status for early-stage ovarian cancer detection.
First FDA approval of Ova1 proteomic assay
Ova1 was the first proteomic in vitro diagnostic multivariate index assay approved by the FDA for clinical use in assessing ovarian cancer malignancy risk.
FDA approval of Overa risk assessment
Overa, Aspira's second-generation blood-based ovarian cancer risk assessment, received FDA approval with an improved positive predictive value of 79%.